Kornimate/medical-research-clean huggingface dataset:
sorafenib combined with transarterial chemoembolization in treating hbv-infected patients with intermediate hepatocellular carcinoma

Conditions: PHENYTOIN/SORAFENIB [VA Drug Interaction]; Liver Neoplasms; Carcinoma, Hepatocellular; Digestive System Neoplasms; Neoplasms by Site; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; DOXORUBICIN/TRASTUZUMAB [VA Drug Interaction]; HBV

Summary: transarterial chemoembolization (tace) is widely used for unresectable hepatocellular carcinoma (hcc). however, the hypoxia caused by tace in surviving tumor cell leads to release of angiogenic and growth factors contributing to poor outcome. sorafenib can block tumor cell proliferation and angiogenesis. the hypothesis is that patients with unresectable hcc may benefit from sorafenib in combination with tace.


Eligibility criteria:
inclusion criteria: * patients newly diagnosed as hcc according to european association for study of the liver criteria. * bclc stage b * child-pugh class a * ecog performance status of 0 * etiology: hepatitis b virus(hbv) infection * written informed consent (approved by the institutional review board \[irb\]obtained prior to any study specific screening procedures * patient must be able to comply with the protocol * age 18-80 years * haematology:absolute neutrophil count (anc) \> 1 x 109/l, platelet count \> 40 x 109/l, haemoglobin \> 9 g/dl (may be transfused to maintain or exceed this level) prothrombin time international normalized ratio \< 1.5 * biochemistry:total bilirubin \< 2 mg/dl serum creatinine \< 1.5 x the upper limit of normal * life expectancy of \> 3 months exclusion criteria: * alanine aminotransferase (alt) and aspartate aminotransferase (ast) \< 5 x the upper limit of normal * other severe concomitant disease that may reduce life expectancy * uncontrolled hypertension * pregnancy (positive serum pregnancy test) or lactation * uncontrolled hypertension * serious, non-healing wound, ulcer, or bone fracture * currently or recent (within the 30 days prior to starting study treatment) treatment of another investigational drug or participation in another investigational study * clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents ( ≤ 6 months prior to study entry), myocardial infarction ( ≤ 6 months prior to study entry), unstable angina, new york heart association (nyha) grade ii or greater congestive heart failure, serious cardiac arrhythmia requiring medication * evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of sorafenib/tace or patient at high risk from treatment complications

Keywords: hepatocellular carcinoma sorafenib transarterial chemoembolization hbv
pharmacokinetics of antiepileptics in patients on crrt

Conditions: Acute Kidney Injury; Renal Insufficiency; Renal Failure; Pharmacokinetics

Summary: the purpose of the study is to measure levels of any of the following aeds (levetiracetam, phenobarbital, phenytoin, ketamine, valproic acid, lacosamide) in blood and effluent on critically ill patients receiving crrt in order to characterize drug pharmacokinetics and optimize dosing strategies in patients on crrt.


Eligibility criteria:
inclusion criteria: * expected to be on crrt and receive any of the following for more than 24 hrs * expected to survive for more than 24 hrs * achievement of steady state drug concentrations prior to study enrollment exclusion criteria: * pregnancy * age \< 18 * prisoner

Keywords: antiepileptics continuous renal replacement therapy
do cobalt chrome stent and paclitaxel-eluting stent have equivalent clinical result in non-complex lesion?

Conditions: Coronary Artery Disease

Summary: we sought to evaluate the long-term safety and efficacy of drug-eluting stent in large vessels compared with bare metal stent.

drug-eluting stent (des) has been proved to reduced restenosis rate dramatically compared to bare metal stent (bms). however, the long-term safety of des is still uncertain. recent meta-analysis showed that very late stent thrombosis rate was higher in des group although overall mortality was similar between 2 groups. the safety issue of des was first suggested in the basket-late study, which compared cobalt chromium alloy bms (vision®, guidant, usa) with sirolimus- or paclitaxel-coated des. the study showed a significantly higher rate of death or myocardial infarction in the des group between 7 and 18 month after the procedure (bms 1.3%, des 4.9%, p=0.01). moreover, benefit to reduce target vessel revascularization was not found and there was even the possibility of late harm in patients treated with des in large native vessels. we perform a multicenter prospective randomized study comparing paclitaxel-eluting stent with cobalt chromium stent several years, originally to see whether major adverse cardiac event is significantly lower in des compared to thin-strut bms in the non-complex lesion subset. in this article, we would like to investigate the 2-year clinical events in des and bms groups.

Eligibility criteria:
inclusion criteria: * angiographically proved significant stenosis in native coronary artery (\> 50% diameter stenosis with ischemic symptoms or positive functional study, or \> 70% diameter stenosis without ischemic symptoms or positive functional study) * planned target lesion number =\< 2 * reference diameter 2.75 - 4.0 mm * lesions can be fully covered by one 28 mm or shorter stent exclusion criteria: * unprotected left main coronary disease with more than 50% stenosis or planned left main angioplasty * ostial target lesion (within 5 mm of ostium) * angiographic evidence of thrombus within target lesion * calcified lesions which cannot be successfully predilated * instent restenosis * multi-vessel intervention more than 2 lesions * atherectomy is planned before stenting * bifurcation lesion that needs side branch ballooning or stenting * severe left ventricular dysfunction with echocardiographic ejection fraction less than 30% * st-elevation myocardial infarction within the preceding 72 hours

Keywords: angioplasty, transluminal, percutaneous coronary paclitaxel-eluting stent vision stent
carnoy's solution versus formalin in rectal and gastric cancer specimens following: a randomized trial

Conditions: Rectal Cancer; Gastric Adenocarcinoma

Summary: this study evaluates the number of lymph nodes dissected in specimens following fixation with 10% neutral buffered formaldehyde or carnoy's solution. specimens were randomized for fixation in each solution.

carnoy's solution is a tissue fixative that has alcohol allowing for fat clearing along with tissue fixation. specimens were randomized after the surgical procedure. the perivisceral fat was removed from the stomach and the lymph node stations disected and then fixed in formalin or carnoy's solution for 24-48h. after dissection the residual fat from the formalin group was re-fixed in carnoy and re-disected.

Eligibility criteria:
inclusion criteria - rectal cancer: * long course neoadjuvant chemoradiation * low anterior resection with total mesorectal excision inclusion criteria - colon cancer: - rectosigmoidectomy inclusion criteria - gastric cancer: * gastric adenocarcinoma * subtotal gastrectomy * d2 lymphadenectomy exclusion criteria - rectal cancer: * previous surgery * incomplete neoadjuvant chemoradiation * refuse to sign the informed consent * t4b and/or multivisceral resection exclusion criteria - colon cancer: * previous surgery * neoadjuvant chemoradiation * refuse to sign the informed consent * t4b and/or multivisceral resection exclusion criteria - gastric cancer: * distant metastasis * previous upper abdomen radiotherapy * previous surgery over stomach or omentum * refuse to sign the informed consent
evaluation of the usefulness of a prn regimen using ranibizumab for macular edema due to branch retinal vein occlusion

Conditions: Branch Retinal Vein Occlusion

Summary: monthly intravitreal ranibizumab (ivr) during the first 6 month had great effect for macular edema with branch retinal vein occlusion (bvo) both in visual and anatomical outcome. it is expected that similar results could be obtained by less frequent ivr. the purpose of this study is to investigate if ivr by prn is as effective as by monthly. in addition, the investigators are going to study the relationship between macular edema and the size and location of retinal non-perfusion area.

it was demonstrated in bravo study that ivr had great effect for macular edema with bvo both in visual and anatomical outcome. however ivr was done monthly for all patients (except sham group) during the first 6 months in bravo study. it is expected that similar results could be obtained by less frequent ivr, and if so, it will contribute to reduce patient's burden and medical cost. thus it is necessary to determine the optimal regimen of ivr therapy. in this study, considering the medical and social circumstances in japan, the investigators are going to investigate if ivr by prn is as effective as bravo study.in addition, the investigators are going to study the relationship between macular edema and the size and location of retinal non-perfusion area (npa), because vegf is thought to be released from non-perfused retinal tissue, and vegf production may be correlated with npa size and location. the investigators are going to measure the size of npa semi-quantatively by ultra wide field fluorescein angiography (uwfa) using optos 200tx. then the relationship with macular edema will be studied. the effect of ranibizumab to npa is controversial. in this study, it will be investigated, too.

Eligibility criteria:
inclusion criteria: * signed informed consent form * macula edema secondary to brvo * bcva of 77 to 20 letters assessed with the use of etdrs charts * crt ≧250μm exclusion criteria: * previous treatment with anti-vegf drugs or corticosteroid or grid laser photocoagulation (study eye) * history of vitrectomy surgery, submacular surgery, or other surgical intervention for rvo * ocular disorders in the study eye that may confound interpretation of study results * bcva over 77 letters between screening and day 0 * the pregnant or lactating woman

Keywords: ranibizumab prn regimen macular edema branch retinal vein occlusion
study of yili mei yi tian active lactobacillus drink to improve immunity and digestive system

Conditions: Immunization; Human Influenza; Common Cold; Constipation; Dyspepsia; Flatulence; Abdominal Pain

Summary: study on evaluating the promote effect of yili mei yi tian active lactobacillus drink on immunity and physical intestinal canal


Eligibility criteria:
inclusion criteria: * age 25 to 45 years sub-health white-collars, catch cold for 4 to 6 times in last year, with low immunity; * non-specific and/or moderate constipation; * irregular or occasional gastrointestinal disorders (flatulence, gurgling, feeling heavy after eating, abdominal pain); * slow transit or irregular bowels movements (abnormal feces solidity, bowel movements decreased, e.g. every 2-3 days or less than 3 times per week); * able to understand the nature and purpose of the study including potential risks and side effects; * willing to consent to study participation and to comply with study requirements exclusion criteria: * diagnosed as immunity-low associated with chronic disease; * diagnosed as chronic constipation; * treated gastrointestinal symptoms; * currently suffering from diarrhea; * suffering from rhinitis chronic, laryngitis, labored breathing that similar to flu symptoms. such as chronic allergic rhinitis, asthma, copd; * treatment by analgesic such as aspirin and paracetamol; * had laxatives or other remedies to promote digestion 2 weeks prior to the study start; * consuming dairy products or supplements containing pro/pre-biotic 10 days prior to the study start; * long-term use of any prescription or otc medication that inhibit or prevent flu symptoms, including but not limited to, antihistamine, pectoral, high doses of vitamin c; * recent use (within 3 months of screening) of any prescription or otc medication that significantly affects immune response, such as antibiotic; * recent inoculation (within 6 months of screening) of influenza vaccine, or other vaccine in 15 days; * history of alcohol, drug, or medication abuse; * pregnant or breastfeeding women; * participation in another study with any investigational product within 3 months of screening * any comorbidity that could, in the opinion of the investigator, preclude the subject's ability to successfully and safely complete the study or that may confound study outcomes
a study of epoetin beta (neorecormon) in predialysis patients with renal anemia

Conditions: Anemia

Summary: this study will evaluate the tolerability, and effect on quality of life, in patients receiving multi-dose neorecormon administered by recopen in predialysis patients with chronic renal anemia. the anticipated time on study treatment is 10 months, and the target sample size is 60 individuals.


Eligibility criteria:
inclusion criteria: * adult patients 18-65 years of age * chronic renal failure (stages i-iii) * no previous epoetin therapy exclusion criteria: * poorly controlled hypertension * history or evidence of malignancy * relevant acute or chronic bleeding (requiring therapy) within 3 months before study drug * women who are pregnant or breastfeeding
non-invasive cardiac output monitoring (escco™) in critically ill patients within icu

Conditions: Cardiac Output

Summary: evaluation of a non-invasive technique to measure cardiac output (escco™) with the "clinical goldstandard" of the transcardiopulmonal thermodilution technique (picco®). effect of different potential interference factors to the accuracy of measurement (changing concentration of norepinephrine, generally severity of the basic disease - apache ii score).

the measurements have to estimate the agreement of escco™ and picco® related to the cardiac output (cardiac index). it should consult a comparison of methods between a complete non-invasive cardiac output monitoring method (escco™) and the transcardiopulmonal thermodilution technique (picco®). the accuracy shall carve out as well as the power of agreement of both measurement methods. it takes two simultaneous measurements at a time of critically ill patients at interdisciplinary surgical intensive care units. furthermore the force of the major variables (1. requirement of norepinephrine and 2. apache ii-score) to the estimators shall be realized. escco™ vs. (picco®) this research shall include 100 patients which have to undergo a complex intensive care treatment within predefined therapy intentions. during a daily screening within the interdisciplinary surgical intensive care units of the universitätsklinikum schleswig-holstein, campus kiel it will be opted for the inclusion of the patients. points of time x \[x ε m and m = {1, 2, 3, 4}\] - two test series (measurement 1 and 2). according to the ability of the patient to the research the predefined point of time number 1 will be supposed (point of time number 1: inclusion criterium). the predefined point of time number 2 will be supposed if the therapy concept is planned or changed. the point of time number 3 is defined as the re-evaluation in the course of changed therapy conceptions. if the medical practitioner team decides to renounce the picco-system, the predefined point of time number 4 has arrived. the requirement of norepinephrine will be registered in every measurement (1 and 2). the apache ii-score will be surveyed each point of time x (see above). the remaining treatment of the patients will be performed in the conventional way by the medical practitioner team within the interdisciplinary surgical intensive care units.

Eligibility criteria:
inclusion criteria: * the extended haemodynamic monitoring procedure picco® has already been established due to the clinical decision making of the medical practitioner team exclusion criteria: * atrial fibrillation * cardiac arrhythmias * cardiac pacemaker * intraaortic counterpulsation * pericardial tamponade * age \< 18 years * missing or incorrect patient consent form

Keywords: cardiac index noninvasive escco picco thermodilution
an observational study to predict the response of erythropoietin treatment in participants with cancer related anemia receiving chemotherapy

Conditions: Anemia - Cancer Related

Summary: the purpose of this observational study is to evaluate the predictors of response to erythropoietin (hormone secreted by kidney that helps in formation of red blood cells in bone marrow) treatment in participants with cancer (abnormal tissue that grows and spreads in the body until it kills) related anemia (decreased number of red blood cells), receiving chemotherapy (treatment of cancer using drugs).

this is an observational, prospective (study following participants forward in time), multi-center (study conducted in more than 1 center) study to identify the predictive factors that will effectively predict the response to erythropoietin treatment in cancer related anemia participants receiving chemotherapy. the entire duration of study will be approximately 1 year. participants will primarily be evaluated for achieving at least 1 gram per deciliter (g per dl) rise in hemoglobin (substance that carries oxygen and gives blood its red color) level after receiving erythropoietin treatment based on national comprehensive cancer institute (nccn) v3.2009 practice guideline criteria. response to erythropoietin treatment will also be predicted using other independent hematological (related to blood) factors like c-reactive protein (crp - is an acute serum protein released from liver). it is associated with low hemoglobin \[substance that carries oxygen and gives blood its red color\] or erythropoietin \[hormone secreted by kidney that helps in formation of red blood cells in bone marrow\] resistance), erythropoietin (epo), hemoglobin, hematocrit (amount of red blood cells in blood), reticulocyte (immature red blood cells) count, ferritin (a protein that stores iron and allows the body to use iron), serum iron (iron is in the blood which is bound to transferrin) and transferring iron binding capacity (tibc), level. number of blood transfusions and participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * participants with non-hematologic malignancy (cancer or other progressively enlarging and spreading tumor, usually fatal if not successfully treated) * participants with life expectancy of at least 6 months based on the investigator's clinical judgment * participants receiving chemotherapy * participants having indication and planning to receiving erythropoietin (dosage and regimen should comply with thai fda approval package insert) * participants who have given consent form exclusion criteria: * participants with anemia due to other factors (i.e., iron, b12 or folate deficiencies, hemolysis \[breakdown in red blood cells\], gastrointestinal bleeding, or any active bleeding) * participants with previous history of erythropoietin treatment * participants who have received blood transfusion within 1 month before starting erythropoietin therapy * pregnant or breast-feeding female participants

Keywords: anemia - cancer related eprex (erythropoietin alfa)
assessing arsenic trioxide in young patients with leukemia or lymphoma who were treated on clinical trial nci-00-c-0070j

Conditions: Leukemia; Lymphoma

Summary: rationale: studying bone marrow and blood samples from patients with leukemia or lymphoma treated with arsenic trioxide may help doctors learn more about cancer. purpose: this research study is assessing arsenic trioxide in young patients with recurrent or refractory leukemia or lymphoma who were treated on clinical trial nci-00-c-0070j.

objectives: * to assess the pharmacokinetic and pharmacodynamic profiles of arsenic trioxide in pediatric patients treated on protocol nci-00-c-0070j. outline: bone marrow or peripheral blood mononuclear cells collected during treatment on nci-00-c-0070j are assessed for pharmacodynamics studies. plasma cells collected during treatment are assessed for pharmacokinetics studies. total arsenic (as), inorganic as forms (asiii and asv), and methylated metabolites of as are assessed.

Eligibility criteria:
disease characteristics: * histologically confirmed leukemia or lymphoma refractory to standard curative treatment regimens * no meningeal leukemia or lymphoma * no hiv-related lymphoma * no lymphoproliferative diseases * received treatment on protocol nci-00-c-0070j * bone marrow or peripheral blood and serum samples collected during treatment on nci-00-c-0070j are available patient characteristics: * see nci-00-c-0070j prior concurrent therapy: * see nci-00-c-0070j

Keywords: recurrent childhood acute myeloid leukemia childhood acute promyelocytic leukemia (m3) recurrent childhood acute lymphoblastic leukemia recurrent childhood large cell lymphoma recurrent childhood lymphoblastic lymphoma recurrent childhood small noncleaved cell lymphoma recurrent/refractory childhood hodgkin lymphoma childhood chronic myelogenous leukemia atypical chronic myeloid leukemia, bcr-abl1 negative
reducing distress in phase 1 trial caregivers: the p1-call study

Conditions: Caregiver Distress

Summary: this study seeks to decrease distress in the lives of the caregivers who are helping cancer patients who have entered a phase 1 clinical trial.

this study seeks to decrease distress in the lives of the caregivers who are helping cancer patients who have entered a phase 1 clinical trial. the p1-call study uses a psychosocial intervention aimed at decreasing distress through the utilization of adaptive coping strategies (e.g., meditation, emotion-focused coping) and cognitive behavioral techniques. caregivers will receive 4 weeks of stress-management sessions (over the phone). then, they will be randomized to receive 4 more weekly sessions of either cognitive behavioral therapy or metta-meditation (over the phone). participants will receive tasks to complete each week.

Eligibility criteria:
inclusion criteria: 1. informal caregiver of a patient screening for a phase 1 clinical trial 2. self-identifies as a caregiver as consistent with the national study of caregiving (nsoc) definition13- individuals who help a patient with self-care, mobility, or household activities (the latter, for health or functioning related reasons) and are either related to the patient (paid or and non-paid) or are unrelated non-paid helpers. 3. provision to sign and date the consent form. 4. completes the patient health questionnaire (phq-4) screener with a total score of \>3. 5. stated willingness to comply with all study procedures and be available for the duration of the study. 6. age \>18 7. has consistent access to a telephone 8. able to read and understand english exclusion criteria: 1. has a cognitive or psychiatric condition prohibiting participation. 2. current enrollment in another psychosocial intervention trial.

Keywords: depression cognitive behavioral therapy coping meditation anxiety